Hypobaric Flight Simulation in COPD Patients
Primary Purpose
COPD, Hypoxia, Aviation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Environmental
Sponsored by
About this trial
This is an interventional basic science trial for COPD
Eligibility Criteria
Inclusion Criteria:
- No lung disease
- COPD without hypercapnea
- COPD with hypercapnea
Exclusion Criteria:
- Claustrophobia
- Renal insufficiency
- Heart failure (ejection fraction < 45 %)
Sites / Locations
- Kloster Grafschaft
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
healthy subjects
COPD normocapnic
COPD hypercapnic
Arm Description
three hour flight simulation
three hour flight simulation
three hour flight simulation
Outcomes
Primary Outcome Measures
Change in six minute walking distance measured in meters
difference between pre- and post-flight walking distance
Secondary Outcome Measures
minimal Oxygen saturation measured by pulse oxymetry in %
Nadir of the oxygen saturation during the flight
Full Information
NCT ID
NCT02848391
First Posted
June 24, 2016
Last Updated
February 28, 2018
Sponsor
Krankenhaus Kloster Grafschaft
1. Study Identification
Unique Protocol Identification Number
NCT02848391
Brief Title
Hypobaric Flight Simulation in COPD Patients
Official Title
Impact of Hypobaric Flight Simulation on Walking Endurance in COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Krankenhaus Kloster Grafschaft
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim of this study was to evaluate the hypoxic response during hypobaric flight simulation in normal individuals as well as in normocapnic and hypercapnic COPD patients as well as to evaluate the impact of a flight simulation on walking endurance in these patients.
Detailed Description
Background and aim:
Commercial aircrafts have their altitude compensation adjusted to 2500 meter above sea level which corresponds to a pressure difference of about 270 hPa. This causes a reduction of the partial pressure of oxygen during the flight. Patients with lung disease are especially challenged by large walking distances within airports and during their journey. The objective of our study is to evaluate the impact of a simulated flight under hyperbaric conditions on walking endurance in healthy individuals as well as in COPD Patients with and without hypercapnia.
Method:
Healthy individuals as well as COPD patients were assessed pre-flight with the following measurements:
Arterial blood gas analysis
Lung function test
Lung diffusion test
Hemoglobin level
Six minute walking distance
During the flight measurements included (measured every 30 minutes until landing):
Heartrate
Oxygen saturation
Borg scale
Post flight measurements included:
Arterial blood gas analysis
Six minute walking distance
Intended analysis:
Description of endurance response as a function of COPD disease severity.
Description of endurance response in normocapnic and hypercapnic COPD patients.
Detection of pre-flight predictors that determine flight tolerability and hypoxic response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Hypoxia, Aviation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
healthy subjects
Arm Type
Experimental
Arm Description
three hour flight simulation
Arm Title
COPD normocapnic
Arm Type
Experimental
Arm Description
three hour flight simulation
Arm Title
COPD hypercapnic
Arm Type
Experimental
Arm Description
three hour flight simulation
Intervention Type
Other
Intervention Name(s)
Environmental
Intervention Description
hypobaric flight simulation
Primary Outcome Measure Information:
Title
Change in six minute walking distance measured in meters
Description
difference between pre- and post-flight walking distance
Time Frame
30 Minutes before and after a 3 hour simulated flight (Time point - 30 and + 210 minutes)
Secondary Outcome Measure Information:
Title
minimal Oxygen saturation measured by pulse oxymetry in %
Description
Nadir of the oxygen saturation during the flight
Time Frame
measurement completed at 180 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
No lung disease
COPD without hypercapnea
COPD with hypercapnea
Exclusion Criteria:
Claustrophobia
Renal insufficiency
Heart failure (ejection fraction < 45 %)
Facility Information:
Facility Name
Kloster Grafschaft
City
Schmallenberg
State/Province
NRW
ZIP/Postal Code
57392
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hypobaric Flight Simulation in COPD Patients
We'll reach out to this number within 24 hrs